BONJELA Gel Ref.[49644] Active ingredients: Alkyldimethylbenzylammonium chloride Choline salicylate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom

4.1. Therapeutic indications

For the relief of pain, discomfort and inflammation caused by common mouth ulcers, cold sores, denture and sore spots, as well as mouth ulcers, and sore spots due to orthodontic devices. To help to fight minor mouth infection and aid healing of sore spots and ulcers due to dentures and orthodontic devices.

4.2. Posology and method of administration

By topical application to the oral mucosa.

Adults and children over the age of 16: Using a clean finger massage approximately half an inch of the gel onto the sore area, not more than once every 3 hours.

There is no indication that dosage need be modified in the elderly.

Denture irritation: Apply and leave at least 30 minutes before reinsertion of the dentures. Do not apply this product directly to the dentures.

4.9. Overdose

Salicylate toxicity can result if the stated dose is exceeded.

Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning. Patients should be given supportive therapy or treatment for salicylate poisoning as necessary. This may include treatment like activated charcoal, urinary alkalinisation and in severe cases haemodialysis.

6.3. Shelf life

Two years.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Gel is contained in an extruded aluminium membrane tube with an internal lacquer, plastic neck insert and plastic tamper-evident closure

Or

In a multi-layered plastic and aluminium tube with silver plastic tamper evident seal and plastic cap.

The 10g and 15g tubes are packed in a cardboard outer carton. The 3g tube is presented on a supporting card.

6.6. Special precautions for disposal and other handling

No special requirements.

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